Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Chinese Heparin Testing Lab Warned by FDA

A Chinese heparin contract testing lab has been warned by the FDA for significant cGMP violations, recalling unresolved questions and concerns from the Chinese heparin scandal a decade ago.

In the June 22 letter from the FDA, China-based Shandong Analysis and Test Center was warned that their drugs are considered adulterated under U.S. federal law, as the lab is not in compliance with current good manufacturing practices for API testing. The lab analyzes samples of heparin and heparin-related drugs for the presence of over-sulfated chondroitin sulfate (OSCS).

During a January 2017 inspection, Shandong Analysis and Test Center was found to have failed to ensure its API testing procedures were scientifically sound.